Preclinical and Clinical Investigations for Evaluating Medical Device Use Conditions

Preclinical and clinical research studies are critical tools for ensuring that our lifesaving medical devices are safe and effective for patients we serve as engineers. Development and approval of medical devices in the USA is controlled under the Federal Food, Drug, and Cosmetic Act (FD&C Act) Chapter V and the Code of Federal Regulations (CFR) Title 21 Parts 1–58, 800–1299. Broadly, preclinical research precedes clinical evaluation of device performance in patients and provides information on how a device might perform in patients using bench testing or a physiological test system (typically an animal model or cadaver). Preclinical research techniques can assess a device’s potential for safety and efficacy prior to human use while clinical research provides direct information on device safety and efficacy in humans. The process for conducting preclinical and clinical research along with specific case studies is presented in this chapter.